Official Title: “A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study Evaluating the Effects of 2 Different Regimens of Montelukast (Daily Dosing and Intermittent, Episode-Driven Dosing) Compared With Placebo in the Treatment of Episodic Asthma in Children Aged 6 Months to 5 Years”

This is a year-long study evaluating the efficacy of both daily and intermittent treatment of asthma in children who experience symptoms episodically (i.e., seasonally, usually in the context of upper respiratory tract infection).

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2009

Intervention(s) in this Clinical Trial

• Drug: montelukast sodium
  • Montelukast 4mg (or 5mg, depending on age of patient) chewable tablet qd + episode driven supplemental montelukast qd for 12 days for a 52-wk treatment period.
• Drug: Comparator: Placebo (unspecified)
  • Daily Pbo qd for 12 days; daily Pbo + episode driven supplemental Pbo for 12 days for a 52-wk treatment period.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Arm 1: drug + episodic supplemental drug
• Active Comparator: 2
  • Arm 2: Pbo comparator + episodic supplemental drug
• Placebo Comparator: 3
  • Arm 3: Pbo comparator + episodic supplemental Pbo

Primary Measures

• Number of asthma episodes culminating in asthma attack over the 1-year treatment period
  • Time Frame: 1-year treatment period
    Safety Issue?: No

Secondary Measures

• Respiratory symptoms over the 1-year treatment period
  • Time Frame: 1-year treatment period
    Safety Issue?: No
• safety and tolerability over the 1-year treatment period
  • Time Frame: 1-year treatment period
    Safety Issue?: Yes

Inclusion Criteria:

• Patients aged 6 Months to 5 years with episodic (periodic) asthma

Exclusion Criteria:

• Patients who are not in otherwise good health
• Patients who have persistent asthma (continual asthma symptoms)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Months

Maximum Age for this Clinical Trial: 5 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Overall Contact: Toll Free Number 1-888-577-8839 

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00337675

Study ID Number: 2006_015

ClinicalTrials.gov Identifier: NCT00337675

Health Authority: United States: Food and Drug Administration

(MedWatch - FDA maintained medical product safety Information)

(PhRMA Clinical Study Results Database - web-based repository for clinical study results)

(Merck: Patient & Caregiver U.S. Product Web Site)